The possible time period of antibiotic therapy for soft-tissue infections of the diabetic foot remained not known. For a study, researchers determined if antibiotic therapy after debridement for a short (10 days), compared with a long (20 days), time period for soft-tissue infections of the diabetic foot resulted in similar rates of clinical remission and adverse events (AE). The adequate duration of systemic antibiotic therapy, after successful debridement, for soft tissue infections of diabetic patients was not known. Because of the high recurrence risk, overuse was usual. This was a randomized, controlled, non-inferiority pilot trial of cases of diabetic foot infection (excluding osteomyelitis) with the primary result of “clinical remission at 2-months follow-up”. Among 66 enrolled episodes (17% females; median age 71 years), investigators randomized 35 to the 10-day arm and 31 to the 20-day arm. The median duration of the parenteral antibiotic therapy was 1 day, with the remainder given orally. In the intention-to-treat population, study group achieved clinical remission in 27 (77%) patients in the 10-day arm, comparable to 22 (71%) in the 20-day arm (P=0.57). There was a similar proportion in each arm of AE (14/35 versus 11/31; P=0.71) and remission in the per-protocol population (25/32 vs. 18/27; P=0.32). Overall, 8 soft tissue DFIs in the 10-day arm and 5 cases in the 20-day arm recurred as new osteomyelitis [8/35 (23%) versus 5/31 (16%); P=0.53]. Overall, the number of recurrences limited to the soft tissues was 4 (6%). By multivariate research, remission rates (intention-to-treat population, hazard ratio 0.6, 95% CI 0.3-1.1; per-protocol population 0.8, 95% CI 0.4-1.5) and AE were not significantly different with a 10-day compared to 20-day course. In this randomized, controlled pilot trial, post-debridement antibiotic therapy for soft tissue DFI for 10 days resulted in similar (and non-inferior) rates of remission and AEs to 20 days. A larger confirmatory trial was underway.
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